Tandem Diabetes receives FDA 510(k) clearance for SteadiSet infusion set (3-day use); plans 7-day submission

TANDEM DIABETES CARE INC

FDA cleared SteadiSet infusion set for up to 3 days of use; submission by subsidiary CapBio.
SteadiSet features integrated inserter with hidden needle for one-handed insertion; for adults with Type 1 diabetes.
Tandem intends to submit separate 510(k) to extend use to up to 7 days; commercial activities delayed until clearance.
No immediate revenue impact; commercial launch deferred pending 7-day clearance.

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